FDA: All Non-Expired Sterile Unique Pharmaceuticals’ Drugs Recalled

The U.S. Food and Drug Administration (FDA) advised that it is alerting health care professionals and consumers regarding a recall of all non-expired drug products meant for sterile use and sold and distributed by Unique Pharmaceuticals Ltd., located in Temple, Texas.

The recalled products include Lot Number 86513, N-Acetyl Cysteine 20 percent, and all other non-expired, purportedly sterile drug products.

Health care professionals are being advised to immediately check their medical supplies and to quarantine all sterile drug products from Unique Pharmaceuticals. These recalled drugs must not be administered patients as the products may be contaminated. What’s more, administration of a non-sterile drug product that is meant to be sterile may lead to serious and potentially life-threatening infections, and even death.

Unique Pharmaceuticals distributed these products nationwide. Most of the product labels include the following words and numbers: Unique Pharmaceuticals, Temple TX USA 76502.

The agency indicated that two recent inspections of the Unique Pharmaceuticals facility that it conducted revealed insanitary conditions. These conditions cause a lack of sterility assurance of drug products produced at that facility. The inspections also revealed sterility failures in a number of lots of drug products that are intended to be sterile, as well as recurring environmental contamination problems and poor sterile production practices.

The FDA issued a formal request to Unique Pharmaceuticals on July 11, 2014 advising the drug manufacture to issue a recall of all of its non-expired, purportedly sterile drug products. The agency also requested that Unique Pharmaceuticals stop its sterile compounding operations.

Unique Pharmaceuticals has agreed to the recall, in response to the FDA’s requests, and is ceasing sterile compounding operations until sufficient corrections are made at its facility.

“Using these products puts patients at an unacceptable risk for serious infection,” said Carol Bennett, acting director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research. “We urge health care professionals to follow recall instructions issued by the firm.”

The FDA indicated that, to date, it is not aware of any reports of illness associated with the use of Unique Pharmaceutical products. Patients who have received any drug product produced by Unique Pharmaceuticals and who are concerned should contact their health care professional, wrote the FDA.

Unique Pharmaceuticals is registered under section 503B of the Federal Food, Drug, and Cosmetic Act (FDCA) as an outsourcing facility. The Drug Quality and Security Act, signed into law on November 27, 2013, added section 503B to the FDCA. Under this section, a compounder may elect to become an outsourcing facility. Outsourcing facilities must comply with current good manufacturing practice requirements; will be subject to inspection by the FDA, according to a risk-based schedule; and must meet certain other requirements, including reporting adverse events and providing the FDA with certain information about the products compounded.